Mezim 20000 20 caps (Mezym forte)

Description

Composition
Active substance:
1 tablet contains:
Pancreatin * – 220.00 – 293.34 mg with minimal activity: lipase 20,000 units 12,000 units protease amylase 900 U * is obtained from pig pancreas.
Excipients:
Lactose monohydrate, microcrystalline cellulose, colloidal silicon dioxide, crospovidone (type A), magnesium stearate. sheath: hypromellose, methacrylic acid ethyl acrylate copolymer (1: 1) dispersion of 30% (dry weight) triethyl citrate, talc, titanium dioxide (E 171), Simethicone emulsion 30% (dry weight), macrogol 6000, carmellose sodium, polysorbate 80, flavoring vanilla flavoring bergamot.
Description:
Round, biconvex tablets, film-coated, white to grayish white color shade, with a smooth surface, with a specific smell, on the fracture possible brown blotches.
Product form:
The tablets, enteric coated, 20000 IU.
10 tablets, enteric-coated in blisters (blister) [aluminum foil / aluminum foil].
1, 2 or 5 blisters with instructions for use in a cardboard package.
Contraindications
Hypersensitivity to any component of the drug;
Acute pancreatitis or chronic pancreatitis in acute stage. Nevertheless, possible to use in the phase of fading exacerbation while expanding diet, if there are signs of digestive disorders;
Hereditary galactose intolerance, the lack of lactase, or syndrome of glucose-galactose malabsorption;
Children under the age of 3 years (for a given dosage form).
Indications
Insufficiency of exocrine pancreatic function (chronic pancreatitis, cystic fibrosis, and so forth.);
Chronic inflammatory and degenerative diseases of the stomach, intestine, liver, gall bladder;
Status after resection or irradiation of the digestive tract, accompanied by impaired digestion of food, flatulence, diarrhea (in combination therapy);
To improve food digestion in patients with normal function of the gastrointestinal tract in the case of errors in the diet;
Preparing to X-ray and ultrasound examination of the abdomen;
Disorders of the digestive tract functional character (acute intestinal infections, irritable bowel syndrome, etc.).
Interaction with other drugs
May decrease absorption of folic acid while the application of pancreatin preparations. The effect of hypoglycemic agents for oral administration (such as acarbose, miglitol) can be reduced while the use of preparations of digestive enzymes containing enzymes that cleave carbohydrates (e.g., amylase).
If you apply the above or any other medicines (including OTC), before use of the drug Mezim® 20000 consult your doctor.
Overdose
Symptoms: hyperuricemia and hyperuricosuria (particularly in cystic fibrosis patients taking high doses of enzyme preparations).
Treatment: symptomatic therapy, removal of the drug.
pharmachologic effect
Pharmacological group:
Digestive enzymatic means.
Pharmacodynamics:
Pancreatin is a powder of porcine pancreatic glands. Pancreatic enzymes are part of the pancreatin have proteolytic, amylolytic and lipolytic effect and contribute to the breakdown of proteins, fats and carbohydrates, improve the functional state of the gastrointestinal tract (GIT) thus normalizing digestion.
Pharmacokinetics:
Tablets 20000 Mezim® drug coated acid resistant coating which is resistant to hydrochloric acid of the stomach and thereby protects the drug contained in the pancreatic enzymes from inactivation. Dissolution of the enteric coating and release of the enzyme occurs at a neutral or slightly alkaline values ​​of pH.
Pregnancy and breast-feeding
Before using the product Mezim® 20,000 if you are pregnant or suspect that you might be pregnant, or planning to become pregnant, you must consult your doctor.
During breastfeeding before application of the drug Mezim® 20000 should consult a physician.
Data on the use of pancreatin during pregnancy and lactation are not available.
During pregnancy and breastfeeding period, the appointment of doctor Pancreatin is possible only if the expected benefit to the mother outweighs the potential risk to the fetus or child.
Conditions of supply of pharmacies
Without recipe.
side effects
Possible side effects are listed below in descending frequency of occurrence: very often (> 1/10), often (> 1/100, 1/1000, 1/10000,
Violations by the immune system
Very rare: immediate type allergic reactions (such as skin rash, hives, sneezing, watery eyes, bronchospasm, dyspnea), hypersensitivity of the gastrointestinal tract.
Disorders of the gastrointestinal tract
Very rare: diarrhea, abdominal discomfort, abdominal pain, nausea, vomiting; stricture formation in ileocecal and ascending sections of the colon in patients with cystic fibrosis with high doses of pancreatin.
Violations of the urogenital system
Frequency unknown: hyperuricosuria (see “Special Instructions” section.).
If you have marked side effects indicated in the instructions or they are compounded, or if you notice any other side effects not mentioned in the instructions, tell your doctor.
special instructions
In acute pancreatitis or chronic pancreatitis exacerbation (worsening in step attenuation) during the reductive Cesky diet food, it is advisable to take the drug on a background Mezim® 20000 having a seat and / or in the further remaining exocrine pancreatic insufficiency.
Patients with cystic fibrosis, especially when high doses of pancreatin may hyperuricosuria occur, so this group of patients is necessary to control the concentration of uric acid in urine.
In the above group of patients described stricture in ileocecal and ascending part of the colon.
As a precaution, the appearance of unusual abdominal discomfort or change in the nature of complaints, especially when taking more than 10,000 IU of lipase / kg body weight per day, you need a medical examination.
Preparation Mezim® 20000 contains active enzymes which when released in the mouth, such as chewing, can damage the mucosa of the oral cavity (including the formation of ulcers). Therefore, the tablet must be swallowed whole.
The drug contains lactose in the composition, so it is contraindicated in patients with hereditary galactose intolerance, lactase deficiency or glucose-galactose syndrome malabsorption.
Effects on ability to drive vehicles, mechanisms:
The drug Mezim® 20,000 have no or little impact on the capacity for road management and other mechanisms.
Storage conditions
At a temperature of not higher than 30 C. Keep out of reach of children !.
Dosing and Administration
Dose Mezim® 20000 set individually depending on the disease and symptom.
Unless indicated otherwise, adults should take 1-2 tablets of the drug Mezim® 20,000 during meal time. The drug is taken orally without chewing or breaking a tablet (20000 Mezim® drug efficacy may be reduced chewiness and pancreatic enzymes when released can irritate the oral mucosa), squeezed enough liquid (e.g. water glass).
The daily dose of pancreatic enzymes, lipases corresponding to 15000-20000 IU / kg body weight not to exceed recommended.
Increasing the dose should be done only under medical supervision, in line with on symptoms (eg, reduction of steatorrhea and abdominal pain).
Duration of treatment is determined by the doctor and can vary from a few days (in violation of digestion due to errors in the diet) to several months or even years (permanent replacement therapy if necessary).
In children, the dosage is determined by the doctor.
The dose for children and adults with cystic fibrosis
In cystic fibrosis patients the dose should be adjusted according to the severity of disease symptoms, steatorrhea monitor results and maintain adequate nutritional status (see. Section “Special Instructions”).
The dose should not exceed 10,000 lipase units / kg body weight per day.
In children, the dosage regimen and duration of treatment is determined by a doctor depending on the severity of digestive disorders and diet composition, the rate of 1000 units of lipase / kg body weight per meal for children under 4 years of age and 500 units of lipase / kg body weight per meals for children over 4 years.
If after treatment there is no improvement or symptoms are aggravated, or there are new symptoms, you should consult with your doctor.
Use according to the drug only indications that the application and in those doses which are specified in the instruction.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist